Mysoline® 250 mg Tablets – patient leaflet, side effects, dosage

1. WHAT MYSOLINE IS AND WHAT IT IS USED FOR

Mysoline tablets contain primidone as the active ingredient; this belongs to a group of medicines used to treat seizures.

Mysoline is used for the treatment of certain types of epilepsy, seizures (fits) or shaking attacks (essential tremor).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYSOLINE

Do not take Mysoline:

• If you are allergic to primidone, phenobarbital, or to any of the other ingredients of this medicine (these are listed in Section 6: Further information).
• If you have porphyria (a rare inherited disorder of metabolism) or anyone in your family has it.

Warnings and precautions

This medication is not effective in certain forms of epilepsy. Your doctor will assess the need to prescribe you this medicine depending on the form of epilepsy you are suffering from.

Consult your doctor immediately if the frequency of your seizures increases or if seizures of a different type appear.

Talk to your doctor or pharmacist before taking Mysoline:

• If you have ever had respiratory, kidneys or liver problems;
• If you are pregnant or are trying to become pregnant (see beneath for further information).

If you go into hospital, tell the medical staff that you are taking Mysoline.

Your doctor may prescribe you Vitamin D supplementation (in case of long-term treatment).

A small number of people being treated with anti-epileptics such as Mysoline have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Mysoline, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.

Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).

These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.

The highest risk for occurrence of serious skin reactions is within the first weeks of treatment.

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Mysoline or any other medicine containing phenobarbital, you must not be re-started on these medicines at any time.

If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him that you are taking this medicine.

Other medicines and Mysoline

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because some medicines may affect the way Mysoline works, or Mysoline may affect the way other medicines work.

In particular, tell your doctor if you are taking any of the following:

• Other medicines used to treat epilepsy and other types of seizures (such as phenytoin, felbamate, valproic acid, carbamazepine, perampanel, lamotrigine, oxcarbazepine, stiripentol, tiagabine, zonisamide)
• Anticoagulants to prevent blood clots (such as acenocoumarol, fluindione, phenindione, warfarin)
• Barbiturates or benzodiazepines (such as sleeping tablets)
• Medicines used to treat severe pain, cough, or as a substitute for morphine addiction (such as methadone, oxycodone or fentanyl)
• Antibiotics (such as metronidazole, doxycycline, telithromycine)
• Asthma medicines (such as theophylline, montelukast)
• Hormone containing medicines (such as the oral contraceptive pill, estroprogestatives, progestatives, ulipristal)
• Thyroid hormones,
• Medicines used to treat high blood pressure or heart conditions (such as beta-blockers, nimodipine)
• Cyclosporine (used to prevent rejection of an organ transplant and also for other diseases of the body’s immune system)
• Medicines used to treat mental health problems or depression (such as lurasidone, tricyclic antidepressants, lamotrigine, mianserin, quetiapine, sertraline)
• Steroid-containing medicines
• Medicines used to treat cancer (such as cyclophosphamide, etoposide, abiraterone, axitinib, eribuline, ifosfamide, bosutinib, crizotinib, dabrafenib, dasatinib, erlotinib, gefitinib, imatinib, lapatinib, nilotinib, pazopanib, ruxolitinib, sorafenib, sunitinib, vandetanib, regorafenib, vemurafenib, vismodegib, cabozantinib, ceritinib, ibrutinib, olaparib, ponatinib, carbazitaxel, docetaxel, irinotecan, procarbazine),
• St-John’s wort
• Medicines containing morphine or similar medicines called opiates
• Bedaquiline, delamanid (used to treat tuberculosis),
• Quinine (used to treat malaria),
• Medicines used to treat viral infections such as HIV infection or hepatitis C (such as boceprevir, cobicistat, daclatasvir, dasabuvir, dolutegravir, lopinavir, maraviroc, nelfinavir, ombitasvir+paritaprevir, rilpivirine, ritonavir, simeprevir, sofosbuvir, telaprevir),
• Anti-fungal medicines (voriconazole, albendazole, itraconazole, posaconazole),
• Anticoagulants (such as apixaban, dabigatran, rivaroxaban or ticagrelor),
• Folates (vitamin B9),
• Medicines used to reduce immunity (immune-suppressants, such as cyclosporine, tacrolimus, sirolimus, everolimus),
• Deferasirox (iron-chelator),
• Medicine used to treat cystic fibrosis (ivacaftor),
• Medicines used to treat a heart disease, high blood pressure or to regulate cardiac rhythms (such as class IA antiarythmics, calcium antagonists, bosentan, dronedarone, ivabradine, macitentan, nimodipine, propafenone, ranolazine or betablockers (metoprolol, propranolol),
• Antiparasite agent (albendazole, praziquantel).

Taking Mysoline with food, drink and alcohol

Alcohol can react with Mysoline. Ask your doctor for advice if you want to drink alcohol.

Pregnancy, breast-feeding and fertility

The use of Mysoline in pregnancy is associated with an increased risk of abnormalities in babies. Mysoline is likely to cause malformations in the unborn child (especially cleft lip and palate, cardiovascular malformations and abnormality of the penis in male babies) when administered during pregnancy. Therefore, you must tell your doctor if you are pregnant, or trying to become pregnant.

Your doctor will talk to you about potential benefit of continuation of the treatment or whether another medication maybe more suitable for you. If you continue treatment,

• During pregnancy: your doctor will adjust your dose to get the minimum effective dose for you. Before delivery: you will need to take vitamin K to prevent the bleeding this medicine may cause during the first 24 hours of your baby's life.
• After childbirth: an injection of vitamin K may also be prescribed to your baby, at birth, to avoid any bleeding.

Do not interrupt your treatment suddenly; this could lead to the recurrence of seizures, which would have serious consequences for you and your child.

It is recommended that you use effective contraception during treatment. Mysoline can make the contraceptive pill ineffective and you should use another effective method of contraception - ask your doctor for advice regarding effective contraception.

Effects in the new born

The new born child may develop withdrawal symptoms if the mother has taken Mysoline in the late stages of pregnancy. Blood clotting problems have occurred occasionally in children born to women who were previously taking anticonvulsant drugs.

1996

03.08.20[23]

Breast-feeding is not recommended as Mysoline is found in breast milk and can make the baby sleepy. Contact your doctor if you are breastfeeding or want to breastfeed.

Driving and using machines

Mysoline can make you feel sleepy. If so, do not drive or operate machinery.

3. HOW TO TAKE MYSOLINE

Always take Mysoline exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The dosage will be determined by your doctor and adjusted gradually on individual basis.

Mysoline is normally taken twice a day. Try to take your tablets at the same time each day. Swallow the tablets whole with a drink of water.

The tablet can be divided into equal doses.

Epilepsy

At first, your dose may be as little as 125 mg (half a 250 mg tablet). This will be adjusted by your doctor until your condition is controlled. Typical maintenance doses are as follows:

Shaking attacks (Essential tremor)

Your starting dose may be 50 mg. This will be adjusted by your doctor until your condition is controlled. The highest dose tolerated for shaking attacks (essential tremor) is up to a maximum of 750 mg.

Elderly / Patients with renal or liver disease

Lower doses may be prescribed. Please check with your doctor.

If you take more Mysoline than you should

If you take more than your normal dose, contact your doctor or nearest hospital.

If you forget to take Mysoline

If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Mysoline

Do not stop taking your Mysoline, even if you are feeling well, unless your doctor tells you to. You may have become dependent on Mysoline, and therefore you could get a withdrawal reaction if you stop treatment too quickly. Mysoline treatment should be reduced gradually to prevent this.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people)

• lack of energy (apathy), coordination disorders, visual disturbances, rolling of the eyes,
• nausea.

Uncommon (may affect up to 1 in 100 people)

• Headache, vertigo
• Vomiting
• Allergic skin reaction

Rare (may affect up to 1 in 1,000 people)

• Decreased number of some blood cells (red blood cells or white blood cells or platelets) or development of lymph nodes.
• Changes in mood or behaviour
• Joint or bone pain, Dupuytren’s contracture (a thickening of fibrous tissue in the palm of the hand that causes one or more fingers to draw back), osteomalacia (bone softening due to vitamin D deficiency)
• Exfoliative dermatitis (common redness and peeling of the skin), lupus erythematosus (disease which causes inflammation of various parts of the body including the skin, joints, lungs, kidneys, heart and liver
• Raised levels of enzymes in your liver (gamma GT, alkaline phosphatase)

Very rare (may affect up to 1 in 10,000 people)

• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).

  Not known (frequency cannot be estimated from the available data)

  • Allergic reactions which may include fever, rash, increased numbers of some blood cells (eosinophils), increased of some liver enzymes
  • There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MYSOLINE

Keep out of the sight and reach of children.

Do not store above 25^oC. Keep container tightly closed.

Protect from light and moisture.

Do not use Mysoline after the expiry date which is stated on the carton as {EXP MM/YYYY}.

The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

If your tablets become discoloured or show any other signs of deterioration, consult your doctor or pharmacist who will tell you what to do.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mysoline contains

Mysoline tablets each contain 250mg of primidone.

Each tablet contains a number of inactive ingredients which allow it to be made. These are calcium carboxymethylcellulose, gelatin, magnesium stearate, povidone and stearic acid.

What Mysoline looks like and contents of the pack

Mysoline tablets are available as white round bi-convex tablets with a scoreline on one side and plain on the other side of the tablet.

Mysoline comes in blister strip packs of 30 tablets.

Manufacturer and product licence holder

Mysoline tablets are manufactured by Laboratorio Farmaceutico SIT S.r.l., VIA Cavour 70, Mede (PV) Italy.

Procured from within the EU by product licence holder Tenolol Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref.) 03.08.20[23]

* Mysoline® is a trademark of SERB.

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POM

PL 30900/1996